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San Francisco HIV Forum Asks: Is Undetectable the New Negative?

More than 100 participants packed the Eureka Valley Recreation Center in San Francisco on May 20 for the latest Real Talk discussion of new HIV prevention strategies including pre-exposure prophylaxis (PrEP) and antiretroviral treatment as prevention.

Given the latest data showing that effective HIV treatment dramatically reduces the risk of sexual transmission -- potentially to near zero -- we need to rethink how we talk about HIV before hooking up, explained Tim Patriarcha, Executive Director of Gay Men's Health and Wellnessat the San Francisco AIDS Foundation, which sponsored the forum.

To make informed decisions about risk today, it is not enough to know whether someone is HIV positive or HIV negative -- or thinks he is -- but also what he's doing in terms of treatment, if positive, or biomedical prevention, if negative.

Treatment as Prevention

"We have to think about what it means to have sex today -- in 2104, not in 1992," urged moderator David Evans of Project Inform. "I remember those very dark years, but we're not there anymore. New research has given people more options."

Not long after the introduction of effective combination antiretroviral therapy (ART) in the mid-1990s, researchers in Uganda and Thailand reported that people on treatment seemed much less likely to transmit the virus to their partners.

In 2011, the HPTN 052 study showed that starting treatment early -- instead of waiting until CD4 T-cells drop -- not only led to better outcomes for the HIV positive partners in mostly heterosexual serodiscordant (mixed status) couples, but also reduced transmission to the negative partners by 96%.

More recently, an interim analysis from the Partner Study revealed no cases of HIV transmission among more than 700 serodiscordant couples -- who altogether had sex more than 30,000 times -- when the positive partner was on treatment with an undetectable viral load. Unlike the earlier studies, 40% of Partner Study participants were gay men, most of whom reported unprotected receptive anal sex. But, as Evans cautioned, seeing no transmissions so far does not mean the risk is zero.

With this data in hand, the question now is, what does it all mean for gay and bi men on an individual level and on a population level? In San Francisco, Evans noted, HIV rates have fallen in recent years. This coincides with a city policy encouraging all people diagnosed with HIV to start treatment promptly, but also with wider adoption of prevention strategies such as serosorting and other "seroadaptive" strategies.

And a diverse range of prevention options is more important than ever, according to an on-the-spot audience phone poll. Almost all participants -- 96% -- said they had ever had sex without a condom. Most (85%) said they'd had sex with someone of a different HIV status, and a further 9% said they weren't sure.

Responses diverged a bit more when it came to decisions about who to have condomless sex with. A majority (60%) said they would rather have condomless sex with someone who is HIV positive with an undetectable viral load, while 19% said they would rather do it with someone HIV negative and 21% said they weren't sure.

Audience members noted that some men using Grindr and other hook-up apps are now declaring not only that they are positive and on treatment, but even what threshold of undetectable viral load they are below. And some negative guys are stating that they are taking PrEP.

So how much trust should we put in what potential partners say about their status? A chorus of voices from the audience murmured "None!" but Evans noted that global studies show most people change their behavior when they find out they are HIV positive. "I'm not suggesting you should put your health in the hands of a stranger," he said, "but most of humanity is basically responsible."

"A lot of us take HIV meds to protect our own immune systems, but also to protect others," said one HIV positive participant.

Others, however, were less confident. A lot of people lie or are unintentionally inaccurate, and alcohol or drugs can impair negotiation and decision-making, they argued. Plus, someone could have recently become infected, when viral load is at its highest.

Beyond that, some people regularly taking ART are still detectable, explained Joanna Eveland of Mission Neighborhood Health Center. Or someone may have temporarily stopped treatment, perhaps due to loss of insurance coverage. "It should be like [an expiration date] on a milk carton, after a certain date you have to change your status," she suggested. "Labels are not binary, they're changing all the time."

It's all about harm reduction, said panelist David Waggoner. "We have to negotiate our own levels of comfort, and we're all going to come to different conclusions about what we're comfortable with and not comfortable with."

What About PrEP?

While the forum's title encouraged a focus on HIV treatment as prevention, PrEP -- or taking antiretrovirals in advance to prevent infection -- was at the forefront of many participants' minds. The audience poll revealed that 70% of participants were themselves using or knew someone who was using PrEP, and 86% think it is a viable option to prevent HIV infection.

New CDC guidelines recommending daily Truvada PrEP recently put the subject in the headlines, and it has been a major topic of debate following controversial remarks by Michael Weinstein of the AIDS Healthcare Foundation -- who called Truvada a "party drug" -- and pioneering AIDS activist Larry Kramer, who said people taking PrEP have "got to have rocks in their heads."

Waggoner's doctor suggested a few years ago, before it was FDA-approved for that purpose, that Truvada PrEP might help him stay negative, after he had requested post-exposure prophylaxis multiple times (taking antiretrovirals after sex to prevent infection).

"It's hard to make decisions about fucking from a study," Waggoner acknowledged. "Unless you're an activist, most people don't know about studies. And one study says one thing, then another says something else."

While it once sounded daunting to take a daily pill, Waggoner said he has gotten used to it and now takes Truvada with lunch every day. He added that he has never experienced side effects.

Eveland explained that while some people starting Truvada can have a "start-up syndrome" with headaches, nausea, and flatulence, these are usually minimal and typically subside. Kidney toxicity and bone loss are potential side effects of one of the drugs in Truvada (tenofovir), but these have not been seen in PrEP studies to date, and regular monitoring can reveal problems before they become serious.

Robert Grant, SFAF's chief medical officer and lead investigator for the iPrEx trial, which showed that PrEP is effective for men who have sex with men, explained that one of strengths of PrEP is that you can take Truvada any time during the day. "You may be drunk at midnight, but you can take it when you're in a calm moment and your life may be better organized."

Further, Truvada offers some forgiveness for an occasional missed dose. "Having used a condom yesterday provides no protection if you don’t use a condom today," Grant continued. "But if [Truvada] has been taken for several months, we think protection may last a few days, maybe as long as a week."

But taking PrEP every day remains the goal, and to encourage good adherence he suggested making PrEP part of a daily routine, like putting the Truvada bottle next to your morning coffee cup.

Asked who is a good candidate for PrEP, Grant replied, "Anyone who wants to take it." This includes people who are not using condoms consistently, people who are breaking up, and couples who desire pregnancy.

"A bad breakup is a situation that should make people ask if maybe they should be taking PrEP for a year," he suggested. "It's not only for sero-different partners, but even more for people who have negative partners who have sex with other partners, or partners of unknown status."

Grant noted that other drugs for PrEP besides Truvada are now under study. These include a long-acting integrase inhibitor, GSK1265744, that could potentially be injected once every 3 months. A safety trial (ÉCLAIR)is just starting in San Francisco for men who are not at risk for HIV but want to contribute to prevention research. Other future prospects include anal or vaginal gels or other products that deliver anti-HIV drugs where they are needed to stop sexual transmission.

A disadvantage of PrEP is that it does not prevent other sexually transmitted infections such as syphilis or gonorrhea. Neither PrEP nor condoms fully protect against human papillomavirus (HPV) -- which can cause genital warts and anal or cervical cancer -- or sexually transmitted hepatitis B or C. So regular sexual health check-ups are important for all sexually active people.

Sex and Stigma

"HIV prevention for gay men is getting more like birth control for straight people," Eveland suggested. "Serosorting is like the rhythm method. Does it reduce risk? Sure, but I wouldn't choose to use my Catholic grandmother's method, since she had eight kids. PrEP is like the birth control pill: very effective if you use it, but with some toxicity."

"There's a lot of controversy about people having too much sex, which happened also with birth control," she added. "That died down, and probably will also around PrEP."

"Condoms are not always available, consent is not always given, and condoms sometimes break," said panelist Aaron Baldwin, picking up the same theme. PrEP provides another option for gay men -- and for others at risk for HIV -- "very much as birth control has for women for the past several decades."

The idea that gay men are using Truvada to have condomless sex that they shouldn't be having -- in someone estimation -- is one of the key issues in the ongoing PrEP debate.

"I'm amazed that in 2014 there's still so much stigma, so much judgment and mean-spiritedness in our community," said Waggoner, who sported a #TruvadaWhore T-shirt. "There's still so much emotion and negative judgment about gay men and their sex lives. The idea that [Truvada] is a party drug is so incredibly offensive -- it's not a party drug, it's a way to live our lives with dignity."

Wrapping up the conversation, Eveland noted that HIV prevention has "come a very long way in the last few years," and the next steps are education for both the community and providers and figuring out how to get more people access to PrEP. "We really are in a bubble here in Sand Francisco," she stressed. "There's still a lot of room for activism and advocacy."

"There are still many doctors that don't know about it," Grant concurred. "They may say just use condoms or have fewer partners. Patients have a role in educating their doctors."

5/23/14